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Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00005787
Recruitment Status : Terminated (Per PI due to poor/inadequate accrual.)
First Posted : January 27, 2003
Last Update Posted : June 1, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

June 2, 2000
January 27, 2003
June 1, 2012
September 1999
January 2002   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00005787 on ClinicalTrials.gov Archive Site
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Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkin's Lymphoma
Ex Vivo Expanded Peripheral Blood Mononuclear Cells for the Elimination of Neutropenia Associated With High Dose Chemotherapy

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Treating the peripheral stem cells in the laboratory may improve the effectiveness of the transplant.

PURPOSE: Phase I trial to study the effectiveness of peripheral stem cell transplantation in patients who have relapsed or refractory non-Hodgkin's lymphoma and who will be treated with high-dose chemotherapy.

OBJECTIVES:

  • Determine the toxicity of ex vivo expanded peripheral blood mononuclear cells (EVE PBMNC) as a supplement to high-dose chemotherapy and conventional autograft in patients with relapsed or refractory non-Hodgkin's lymphoma.
  • Compare the effect of EVE PBMNC on white blood cell, red blood cell, and platelet recovery in patients on this study vs historical controls, matched by protocol, disease status, and prior therapy.
  • Determine the optimal duration of culture and time of harvest for the production of neutrophils in vivo.
  • Determine the relationships between length of culture, immunophenotype, and clinical outcome.
  • Determine the required numbers of white blood cell precursors for clinical efficacy.
  • Assess the need for multiple transfusions of EVE PBMNC during the post-transplantation period.

OUTLINE: Autologous peripheral blood mononuclear cells (PBMNC) are harvested. Unselected PBMNC are cultured and expanded ex vivo in flt3 ligand, interleukin-3, filgrastim (G-CSF), sargramostim (GM-CSF), and epoetin alfa for 13 days. Expanded PBMNC are reinfused on day 0.

Patients are followed monthly for 1 year.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Interventional
Phase 1
Primary Purpose: Supportive Care
  • Lymphoma
  • Neutropenia
  • Biological: epoetin alfa
  • Biological: filgrastim
  • Biological: recombinant flt3 ligand
  • Biological: recombinant interleukin-3
  • Biological: sargramostim
  • Procedure: in vitro-treated peripheral blood stem cell transplantation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
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January 2002
January 2002   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically proven relapsed or refractory non-Hodgkin's lymphoma
  • Scheduled to undergo high-dose chemotherapy (carmustine, etoposide, cytarabine, and melphalan) with autologous peripheral blood mononuclear cell transplantation
  • No metastatic disease involving the bone marrow

PATIENT CHARACTERISTICS:

Age:

  • 17 to 65

Performance status:

  • ECOG 0 or 1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • No active hepatitis B or C
  • Bilirubin less than 2.5 times normal*
  • SGOT or SGPT less than 2.5 times normal*
  • Alkaline phosphatase less than 2.5 times normal NOTE: * Unless Gilbert's syndrome present

Renal:

  • Creatinine clearance greater than 50 mL/min

Cardiovascular:

  • Cardiac ejection fraction normal

Pulmonary:

  • DLCO at least 50% predicted
  • FEV_1 and FVC at least 75% predicted

Other:

  • HIV negative
  • Not pregnant
  • Negative pregnancy test
  • No non-neoplastic disease that would preclude intensive chemotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior external beam radiotherapy to more than 25% of the active bone marrow

Surgery:

  • Not specified
Sexes Eligible for Study: All
17 Years to 65 Years   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00005787
NU 99Z1
NU-99Z1
NCI-G00-1734
Yes
Not Provided
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Northwestern University
Northwestern University
National Cancer Institute (NCI)
Study Chair: Jane N. Winter, MD Robert H. Lurie Cancer Center
Northwestern University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP